What does "non-compliance" refer to in drug regulations?

Non-compliance in the context of drug regulations refers to any violation of regulation requirements. This encompasses a wide range of actions or failures to act that do not adhere to established laws or guidelines governing the handling, dispensing, or prescribing of controlled substances. This can include activities such as failing to maintain proper records, not following appropriate safety protocols, neglecting to obtain necessary licenses, or inaccurately reporting to authorities.

Understanding non-compliance is critical because it can lead to severe consequences, including legal penalties, loss of licenses, or harm to public health. Regulatory agencies establish strict guidelines to ensure the safe and effective use of medications. Non-compliance undermines these efforts, posing risks not only to individual patients but also to the community at large.